Reservoir filling systems and methods

ABSTRACT

A method of making a system for transferring fluidic media may include placing a reservoir body in an aseptic environment; filling an interior volume of the reservoir body with fluidic media; placing a plunger head into the reservoir body, the plunger head adapted to be movable in an axial direction within the reservoir body; removing the reservoir body from the aseptic environment; and attaching a casing adjacent to at least a portion of the reservoir body with the reservoir body outside the aseptic environment, the casing configured to envelope at least a portion of a plunger arm operatively connected to the plunger head, the casing further configured to allow the plunger arm to move in the axial direction relative to the reservoir body and at least partially within the reservoir body.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a Continuation-In-Part of U.S. application Ser. No.12/499,283, filed Jul. 8, 2009, incorporated herein by reference in itsentirety.

BACKGROUND

1. Field of the Invention

Embodiments of the present invention relate generally to systems andmethods that include reservoirs for containing fluidic media and havingmovable plungers and, in specific embodiments, to infusion mediumdelivery systems and methods employing such reservoirs.

2. Related Art

According to modern medical techniques, certain chronic diseases may betreated by delivering a medication or other substance to the body of apatient. For example, diabetes is a chronic disease that is commonlytreated by delivering defined amounts of insulin to a patient atappropriate times. Traditionally, manually operated syringes and insulinpens have been employed for delivering insulin to a patient. Morerecently, modern systems have been designed to include programmablepumps for delivering controlled amounts of medication to a patient.

Pump type delivery devices have been configured in external devices,which connect to a patient, and have been configured in implantabledevices, which are implanted inside of the body of a patient. Externalpump type delivery devices include devices designed for use in astationary location, such as a hospital, a clinic, or the like, andfurther include devices configured for ambulatory or portable use, suchas devices designed to be carried by a patient, or the like. Externalpump-type delivery devices may contain reservoirs of fluidic media, suchas, but is not limited to, insulin.

External pump-type delivery devices may be connected in fluid flowcommunication to a patient or user-patient, for example, throughsuitable hollow tubing. The hollow tubing may be connected to a hollowneedle that is designed to pierce the skin of the patient and to deliverfluidic media there through. Alternatively, the hollow tubing may beconnected directly to the patient as through a cannula, or the like.

Examples of some external pump type delivery devices are described inU.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled“Infusion Device And Method With Disposable Portion” and Published PCTApplication WO 01/70307 (PCT/US01/09139) titled “Exchangeable ElectronicCards For Infusion Devices” (each of which is owned by the assignee ofthe present invention), Published PCT Application WO 04/030716(PCT/US2003/028769) titled “Components And Methods For Patient InfusionDevice,” Published PCT Application WO 04/030717 (PCT/US2003/029019)titled “Dispenser Components And Methods For Infusion Device,” U.S.Patent Application Publication No. 2005/0065760 titled “Method ForAdvising Patients Concerning Doses Of Insulin,” and U.S. Pat. No.6,589,229 titled “Wearable Self-Contained Drug Infusion Device,” each ofwhich is incorporated herein by reference in its entirety.

External pump-type delivery devices may be connected in fluid-flowcommunication to a patient-user, for example, through suitable hollowtubing. The hollow tubing may be connected to a hollow needle that isdesigned to pierce the patient-user's skin and deliver an infusionmedium to the patient-user. Alternatively, the hollow tubing may beconnected directly to the patient-user as or through a cannula or set ofmicro-needles.

In contexts in which the hollow tubing is connected to the patient-userthrough a hollow needle that pierces skin of the user-patient, a manualinsertion of the needle into the patient-user can be somewhat traumaticto the user-patient. Accordingly, insertion mechanisms have been made toassist the insertion of a needle into the user-patient, whereby a needleis forced by a spring to move quickly from a retracted position into anextended position. As the needle is moved into the extended position,the needle is quickly forced through the skin of the user-patient in asingle, relatively abrupt motion that can be less traumatic to certainuser-patients as compared to a slower, manual insertion of a needle.While a quick thrust of the needle into the skin of the user-patient maybe less traumatic to some user-patients than a manual insertion, it isbelieved that, in some contexts, some user-patients may feel less traumaif the needle is moved a very slow, steady pace.

Examples of insertion mechanisms that may be used with and may be builtinto a delivery device are described in: U.S. patent application Ser.No. 11/645,435, filed Dec. 26, 2006, titled “Infusion Medium Deliverysystem, Device And Method With Needle Inserter And Needle InserterDevice And Method,”; and U.S. patent application Ser. No. 11/211,095,filed Aug. 23, 2005, titled “Infusion Device And Method With DisposablePortion” (each of which is assigned to the assignee of the presentinvention), each of which is incorporated herein by reference in itsentirety. Other examples of insertion tools are described in U.S. PatentApplication Publication No. 2002/0022855, titled “Insertion Device ForAn Insertion Set And Method Of Using The Same” (assigned to the assigneeof the present invention), which is incorporated herein by reference inits entirety. Other examples of needle/cannula insertion tools that maybe used (or modified for use) to insert a needle and/or cannula, aredescribed in, for example U.S. patent application Ser. No. 10/389,132filed Mar. 14, 2003, and entitled “Auto Insertion Device For SilhouetteOr Similar Products,” and/or U.S. patent application Ser. No. 10/314,653filed Dec. 9, 2002, and entitled “Insertion Device For Insertion Set andMethod of Using the Same,” both of which are incorporated herein byreference in their entirety.

Pump-type delivery devices can allow accurate doses of insulin to becalculated and delivered automatically to a patient-user at any timeduring the day or night. Furthermore, when used in conjunction withglucose sensors or monitors, insulin pumps may be automaticallycontrolled to provide appropriate doses of infusion medium atappropriate times of need, based on sensed or monitored levels of bloodglucose.

Pump-type delivery devices have become an important aspect of modernmedical treatments of various types of medical conditions, such asdiabetes. As pump technologies improve and as doctors and patient-usersbecome more familiar with such devices, the popularity of externalmedical infusion pump treatment increases and is expected to increasesubstantially over the next decade.

SUMMARY OF THE DISCLOSURE

A method of making a system for transferring fluidic media may include,but is not limited to, any one or combination of: (i) placing areservoir body in an aseptic environment; (ii) filling an interiorvolume of the reservoir body with fluidic media; (iii) placing a plungerhead into the reservoir body, the plunger head adapted to be movable inan axial direction within the reservoir body; (iv) removing thereservoir body from the aseptic environment; (v) attaching a casingadjacent to at least a portion of the reservoir body with the reservoirbody outside the aseptic environment, the casing configured to envelopeat least a portion of a plunger arm operatively connected to the plungerhead, the casing further configured to allow the plunger arm to move inthe axial direction relative to the reservoir body and at leastpartially within the reservoir body.

In various embodiments, the method may further include operativelyconnecting the plunger arm to the plunger head with the reservoir bodyoutside the aseptic environment. In various embodiments, the plunger armmay be operatively connected to the plunger head before the casing isattached to the reservoir body. In various embodiments, the method mayfurther include locating the plunger arm at least partially in thecasing; and operatively connecting the plunger arm to the plunger headafter the casing is attached to the reservoir body.

In various embodiments, the plunger arm and the plunger head may beintegral with one another.

In various embodiments, attaching a casing adjacent to at least aportion of the reservoir body may include welding the casing to thereservoir body. In some embodiments, the casing may be laser welded tothe reservoir body.

A method of making and filling a reservoir with a selectable amount offluidic media may include, but is not limited to, any one or combinationof: (i) providing a reservoir body with a wall and a central bore, thereservoir body having a first portion with a first fluidic capacity, anda second portion axially aligned with the first portion with anadditional fluidic capacity; (ii) providing a plunger head dimensionedto sealingly slide axially within the bore and thereby propel fluidicmedia in the bore; (iii) providing a selectively breakable zone thatseparates the first portion and the second portion of the reservoirbody; (iv) selecting whether: (a) to fill only the first portion of thereservoir body with fluidic media, in which case the method includesfilling the first portion of the reservoir body with fluidic media,inserting the plunger head to a position in the bore to seal the firstportion of the reservoir body, and breaking off the wall at theselectively breakable zone; or (b) to fill the first portion and thesecond portion of the reservoir body with fluidic media, in which casethe method includes filling the first portion and the second portion ofthe reservoir body with fluidic media and inserting the plunger head toa position in the bore to seal the second portion of the reservoir body.

In various embodiments, the method may further include scoring aperimeter around the reservoir body to form the selectively breakablezone. In some embodiments, a portion of the wall defining the firstportion of the reservoir body may have a thickness different from athickness of a portion of the wall defining the second portion of thereservoir body. In some embodiments, the method may further includeproviding a portion of the reservoir body corresponding to a perimetermade of a different material than a material of the first portion of thereservoir body to provide said selectively breakable zone.

In various embodiments, the selectively breakable zone may includeperforations around the reservoir body. In some embodiments, thethickness of the first portion of the reservoir body may be less thanthe thickness of the second portion of the reservoir body.

In various embodiments, the second portion of the reservoir body may bemade of a material different from a material of the first portion of thereservoir body.

In various embodiments, the selectively breakable zone may be producedby providing an annular body sized and dimensioned to fit around atleast a portion of the reservoir body. The annular body may separate thefirst portion of the reservoir body and the second portion of thereservoir body.

In various embodiments, the filling of the reservoir body and theinsertion of the plunger head in the reservoir body may occur in anaseptic environment. In some embodiments, the reservoir body may beremoved from the aseptic environment prior to breaking off the wallalong the selectively breakable zone.

In various embodiments, the method may further include operativelyconnecting a plunger arm to the plunger head. In some embodiments, theplunger arm and the plunger head may be integral with one another.

In various embodiments, the method may further include attaching acasing adjacent to at least a portion of the reservoir body, the casingconfigured to envelop at least a portion of a plunger arm operativelyconnected to the plunger head. The casing may be further configured toallow the plunger arm to move in an axial direction relative to thereservoir body and at least partially within the reservoir body. In someembodiments, the method may further include locating the plunger arm atlest partially in the casing; and operatively connecting the plunger armto the plunger head after the casing is attached to the reservoir body.

In some embodiments, attaching a casing adjacent to at least a portionof the reservoir body may include welding the casing to the reservoirbody. In further embodiments, the casing may be laser welded to thereservoir body.

In various embodiments, selectively filling the reservoir body mayinclude filling the reservoir body to a fill line. In variousembodiments, a portion of the wall defining the first portion of thereservoir body may have a thickness different from a thickness of aportion of the wall defining the second portion of the reservoir body.

In various embodiments, the reservoir body may have a third portion witha third fluidic capacity. Providing the selectivity breakable zone mayinclude providing at least a first selectively breakable zone thatseparates the first portion and the second portion of the reservoir bodyand a second selectively breakable zone that separates the secondportion and the third portion of the reservoir body. Selecting whether(a) to fill only the first portion of the reservoir body with fluidicmedia, in which case the method includes filling the first portion ofthe reservoir body with fluidic media, inserting the plunger head to aposition in the bore to seal the first portion of the reservoir body,and breaking off the wall at the first selectively breakable zone; (b)to fill the first portion and the second portion of the reservoir bodywith fluidic media, in which case the method includes filling the firstportion and the second portion of the reservoir body with fluidic media,inserting the plunger head to a position in the bore to seal the secondportion of the reservoir body, and breaking off the wall at the secondselectively breakable zone; or (c) to fill the first portion, the secondportion, and the third portion of the reservoir body with fluidic media,in which case the method includes filling the first portion, the secondportion, and the third portion of the reservoir body with fluidic mediaand inserting the plunger head to a position in the bore to seal thethird portion of the reservoir body.

A system for containing fluidic media may include, but is not limitedto, a reservoir body and a plunger head. The reservoir body may have awall and a central bore. The reservoir body may have a first portionwith a first fluidic capacity and a second portion axially aligned withthe first portion with an additional fluidic capacity. The plunger headmay be dimensioned to sealingly slide axially within the bore andthereby propel fluidic media in the bore. The wall of the reservoir bodyincludes a selectively breakable zone that separates the first portionand the second portion of the reservoir body. The selectively breakablezone may be for allowing selective filling of the reservoir body suchthat (i) in a case where only the first portion of the reservoir body isto be filled with fluidic media, the plunger head is positioned in thebore to seal to seal the first portion of the reservoir body, and thesecond portion of the reservoir body is removable from the first portionof the reservoir at the selectively breakable zone; and (ii) in a casewhere the first portion and the second portion of the reservoir body areto be filled with fluidic media, the plunger head is positioned in thebore to seal to seal the second portion of the reservoir body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a generalized representation of a system inaccordance with an embodiment of the present invention;

FIG. 2 illustrates an example of a system in accordance with anembodiment of the present invention;

FIG. 3 illustrates an example of a delivery device in accordance with anembodiment of the present invention;

FIG. 4 illustrates a delivery device in accordance with an embodiment ofthe present invention;

FIG. 5A illustrates a durable portion of a delivery device in accordancewith an embodiment of the present invention;

FIG. 5B illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 5C illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6A illustrates a disposable portion of a delivery device inaccordance with an embodiment of the present invention;

FIG. 6B illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6C illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIGS. 7A and 7B illustrate a cross-section of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 8 illustrates an exploded view of a system for transferring fluidicmedia in accordance with an embodiment of the present invention;

FIG. 9 illustrates a system for transferring fluidic media in accordancewith an embodiment of the present invention;

FIG. 10 illustrates a portion of a system for transferring fluidic mediain accordance with an embodiment of the present invention;

FIG. 11 illustrates a cross-section of a portion of a system fortransferring fluidic media in accordance with an embodiment of thepresent invention;

FIG. 12 illustrates a flow chart of a process of making a system fortransferring fluidic media in accordance with an embodiment of thepresent invention;

FIG. 13 illustrates a flowchart of a process for making a system forcontaining fluidic media in accordance with an embodiment of the presentinvention;

FIG. 14A illustrates a cross-section of a reservoir body in accordancewith an embodiment of the present invention;

FIG. 14B illustrates a cross-section of a reservoir body in accordancewith an embodiment of the present invention;

FIG. 14C illustrates a cross-section of a reservoir body in accordancewith an embodiment of the present invention; and

FIG. 14D illustrates a cross-section of a reservoir body in accordancewith an embodiment of the present invention.

DETAILED DESCRIPTION

FIG. 1 illustrates a generalized representation of a system 10 inaccordance with an embodiment of the present invention. The system 10may include a delivery device 12. The system 10 may further include asensing device 14, a command control device (CCD) 16, and a computer 18.In various embodiments, the delivery device 12 and the sensing device 14may be secured at desired locations on the body 5 of a patient oruser-patient 7. In some embodiments, the sensing device 14 and thedelivery device 12 may be at the same location. In other embodiments,the sensing device 14 and the delivery device 12 may be adjacent eachother. In yet other embodiments, the sensing device 14 and the deliverydevice 12 may share a housing. The locations at which the deliverydevice 12 and the sensing device 14 are secured to the body 5 of theuser-patient 7 in FIG. 1 are provided only as representative,non-limiting, examples. It should be noted user-patient as usedthroughout the disclosure or similar term may include patient-user,patient, or user (e.g., a patient, a medical professional, or othertreating the patient).

The system 10, the delivery device 12, the sensing device 14, the CCD16, and computer 18 may be similar to those described in the followingU.S. Patent Applications that were assigned to the assignee of thepresent invention, where each of following patent applications isincorporated herein by reference in its entirety: (i) U.S. patentapplication Ser. No. 11/211,095, filed Aug. 23, 2005, “Infusion DeviceAnd Method With Disposable Portion”; (ii) U.S. patent application Ser.No. 11/515,225, filed Sep. 1, 2006, “Infusion Medium Delivery Device AndMethod With Drive Device For Driving Plunger In Reservoir”; (iii) U.S.patent application Ser. No. 11/588,875, filed Oct. 27, 2006, “SystemsAnd Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (iv) U.S. patent application Ser. No. 11/588,832, filed Oct.27, 2006, “Infusion Medium Delivery Device And Method With Drive DeviceFor Driving Plunger In Reservoir”; (v) U.S. patent application Ser. No.11/588,847, filed Oct. 27, 2006, “Infusion Medium Delivery Device AndMethod With Compressible Or Curved Reservoir Or Conduit”; (vi) U.S.patent application Ser. No. 11/589,323, filed Oct. 27, 2006, “InfusionPumps And Methods And Delivery Devices And Methods With Same”; (vii)U.S. patent application Ser. No. 11/602,173, filed Nov. 20, 2006,“Systems And Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (viii) U.S. patent application Ser. No. 11/602,052, filedNov. 20, 2006, “Systems And Methods Allowing For Reservoir Filling AndInfusion Medium Delivery”; (ix) U.S. patent application Ser. No.11/602,428, filed Nov. 20, 2006, “Systems And Methods Allowing ForReservoir Filling And Infusion Medium Delivery”; (x) U.S. patentapplication Ser. No. 11/602,113, filed Nov. 20, 2006, “Systems AndMethods Allowing For Reservoir Filling And Infusion Medium Delivery”;(xi) U.S. patent application Ser. No. 11/604,171, filed Nov. 22, 2006,“Infusion Medium Delivery Device And Method With Drive Device ForDriving Plunger In Reservoir”; (xii) U.S. patent application Ser. No.11/604,172, filed Nov. 22, 2006, “Infusion Medium Delivery Device AndMethod With Drive Device For Driving Plunger In Reservoir”; (xiii) U.S.patent application Ser. No. 11/606,703, filed Nov. 30, 2006, “InfusionPumps And Methods And Delivery Devices And Methods With Same”; (xiv)U.S. patent application Ser. No. 11/606,836, filed Nov. 30, 2006,“Infusion Pumps And Methods And Delivery Devices And Methods With Same”;U.S. patent application Ser. No. 11/636,384, filed Dec. 8, 2006,“Infusion Medium Delivery Device And Method With Compressible Or CurvedReservoir Or Conduit”; (xv) U.S. patent application Ser. No. 11/645,993,filed Dec. 26, 2006, “Infusion Medium Delivery Device And Method WithCompressible Or Curved Reservoir Or Conduit”; U.S. patent applicationSer. No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; (xvi) U.S. patent application Ser. No. 11/646,052,filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And MethodWith Needle Inserter And Needle Inserter Device And Method”; (xvii) U.S.patent application Ser. No. 11/645,435, filed Dec. 26, 2006, “InfusionMedium Delivery System, Device And Method With Needle Inserter AndNeedle Inserter Device And Method”; (xviii) U.S. patent application Ser.No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod”; and (xix) U.S. patent application Ser. No. 11/759,725, filedJun. 7, 2007, “Infusion Medium Delivery Device And Method With DriveDevice For Driving Plunger In Reservoir”. In other embodiments, thesystem 10, delivery device 12, sensing device 14, CCD 16, and computer18 may have other suitable configurations.

The delivery device 12 may be configured to deliver fluidic media to thebody 5 of the user-patient 7. In various embodiments, fluidic media mayinclude a liquid, a fluid, a gel, or the like. In some embodiments,fluidic media may include a medicine or a drug for treating a disease ora medical condition. For example, fluidic media may include insulin fortreating diabetes, or may include a drug for treating pain, cancer, apulmonary disorder, HIV, or the like. In some embodiments, fluidic mediamay include a nutritional supplement, a dye, a tracing medium, a salinemedium, a hydration medium, or the like.

The sensing device 14 may include a sensor, a monitor, or the like, forproviding sensor data or monitor data. In various embodiments, thesensing device 14 may be configured to sense a condition of theuser-patient 7. For example, the sensing device 14 may includeelectronics and enzymes reactive to a biological condition, such as ablood glucose level, or the like, of the user-patient 7.

In various embodiments, the sensing device 14 may be secured to the body5 of the user-patient 7 or embedded in the body 5 of the user-patient 7at a location that is remote from the location at which the deliverydevice 12 is secured to the body 5 of the user-patient 7. In variousother embodiments, the sensing device 14 may be incorporated within thedelivery device 12 or share a common housing. In other embodiments, thesensing device 14 may be separate and apart from the delivery device,and may be, for example, part of the CCD 16. In such embodiments, thesensing device 14 may be configured to receive a biological sample,analyte, or the like, to measure a condition of the user-patient 7.

In further embodiments, the sensing device 14 and/or the delivery device12 may utilize a closed-loop system. Examples of sensing devices and/ordelivery devices utilizing closed-loop systems may be found at, but arenot limited to, the following references: (i) U.S. Pat. No. 6,088,608,entitled “Electrochemical Sensor And Integrity Tests Therefor”; (ii)U.S. Pat. No. 6,119,028, entitled “Implantable Enzyme-Based MonitoringSystems Having Improved Longevity Due To Improved Exterior Surfaces”;(iii) U.S. Pat. No. 6,589,229, entitled “Implantable Enzyme-BasedMonitoring Systems Adapted for Long Term Use”; (iv) U.S. Pat. No.6,740,072, entitled “System And Method For Providing Closed LoopInfusion Formulation Delivery”; (v) U.S. Pat. No. 6,827,702, entitled“Safety Limits For Closed-Loop Infusion Pump Control”; (vi) U.S. Pat.No. 7,323,142, entitled “Sensor Substrate And Method Of FabricatingSame”; (vii) U.S. patent application Ser. No. 09/360,342, filed Jul. 22,1999, entitled “Substrate Sensor”; and (viii) U.S. Provisional PatentApplication Ser. No. 60/318,060, filed Sep. 7, 2001, entitled “SensingApparatus and Process”, all of which are incorporated herein byreference in their entirety.

In such embodiments, the sensing device 14 may be configured to sense acondition of the user-patient 7, such as, but not limited to, bloodglucose level, or the like. The delivery device 12 may be configured todeliver fluidic media in response to the condition sensed by the sensingdevice 14. In turn, the sensing device 14 may continue to sense a newcondition of the user-patient, allowing the delivery device 12 todeliver fluidic media continuously in response to the new conditionsensed by the sensing device 14 indefinitely. In some embodiments, thesensing device 14 and/or the delivery device 12 may be configured toutilize the closed-loop system only for a portion of the day, forexample only when the user-patient is asleep or awake.

Each of the delivery device 12, the sensing device 14, the CCD 16, andthe computer 18 may include transmitter, receiver, or transceiverelectronics that allow for communication with other components of thesystem 10. The sensing device 14 may be configured to transmit sensordata or monitor data to the delivery device 12. The sensing device 14may also be configured to communicate with the CCD 16. The deliverydevice 12 may include electronics and software that are configured toanalyze sensor data and to deliver fluidic media to the body 5 of theuser-patient 7 based on the sensor data and/or preprogrammed deliveryroutines.

The CCD 16 and the computer 18 may include electronics and othercomponents configured to perform processing, delivery routine storage,and to control the delivery device 12. By including control functions inthe CCD 16 and/or the computer 18, the delivery device 12 may be madewith more simplified electronics. However, in some embodiments, thedelivery device 12 may include all control functions, and may operatewithout the CCD 16 and the computer 18. In various embodiments, the CCD16 may be a portable electronic device. In addition, in variousembodiments, the delivery device 12 and/or the sensing device 14 may beconfigured to transmit data to the CCD 16 and/or the computer 18 fordisplay or processing of the data by the CCD 16 and/or the computer 18.

In some embodiments, the sensing device 14 may be integrated into theCCD 16. Such embodiments may allow the user-patient to monitor acondition by providing, for example, a sample of his or her blood to thesensing device 14 to assess his or her condition. In some embodiments,the sensing device 14 and the CCD 16 may be for determining glucoselevels in the blood and/or body fluids of the user-patient without theuse of, or necessity of, a wire or cable connection between the deliverydevice 12 and the sensing device 14 and/or the CCD 16.

In some embodiments, the CCD 16 may be for providing information to theuser-patient that facilitates the user-patient's subsequent use of adrug delivery system. For example, the CCD 16 may provide information tothe user-patient to allow the user-patient to determine the rate or doseof medication to be administered into the body of the user-patient. Inother embodiments, the CCD 16 may provide information to the deliverydevice 12 to control the rate or dose of medication administered intothe body of the user-patient

Examples of the types of communications and/or control capabilities, aswell as device feature sets and/or program options may be found in thefollowing references: (i) U.S. patent application Ser. No. 10/445,477,filed May 27, 2003, entitled “External Infusion Device with RemoteProgramming, Bolus Estimator and/or Vibration Alarm Capabilities”; (ii)U.S. patent application Ser. No. 10/429,385, filed May 5, 2003, entitled“Handheld Personal Data Assistant (PDA) with a Medical Device and Methodof Using the Same”; and (iii) U.S. patent application Ser. No.09/813,660, filed Mar. 21, 2001, entitled “Control Tabs for InfusionDevices and Methods of Using the Same,” all of which are incorporatedherein by reference in their entirety.

FIG. 2 illustrates an example of the system 10 in accordance with anembodiment of the present invention. The system 10 in accordance withthe embodiment illustrated in FIG. 2 includes the delivery device 12 andthe sensing device 14. The delivery device 12 in accordance with anembodiment of the present invention may include a disposable housing 20,a durable housing 30, and a reservoir system 40. The delivery device 12may further include an infusion path 50.

Elements of the delivery device 12 that ordinarily contact the body of auser-patient or that ordinarily contact fluidic media during operationof the delivery device 12 may be considered as a disposable portion ofthe delivery device 12. For example, a disposable portion of thedelivery device 12 may include the disposable housing 20 and thereservoir system 40. The disposable portion of the delivery device 12may be recommended for disposal after a specified number of uses.

On the other hand, elements of the delivery device 12 that do notordinarily contact the body of the user-patient or fluidic media duringoperation of the delivery device 12 may be considered as a durableportion of the delivery device 12. For example, a durable portion of thedelivery device 12 may include the durable housing 30, electronics (notshown in FIG. 2), a drive device having a motor and drive linkage (notshown in FIG. 2), and the like. Elements of the durable housing portionof the delivery device 12 are typically not contaminated from contactwith the user-patient or fluidic media during normal operation of thedelivery device 12 and, thus, may be retained for re-use with replaceddisposable portions of the delivery device 12.

In various embodiments, the disposable housing 20 may support thereservoir system 40 and has a bottom surface (facing downward and intothe page in FIG. 2) configured to secure to the body of theuser-patient. An adhesive may be employed at an interface between thebottom surface of the disposable housing 20 and the skin of theuser-patient to adhere the disposable housing 20 to the skin of theuser-patient. In various embodiments, the adhesive may be provided onthe bottom surface of the disposable housing 20, with a peelable coverlayer covering the adhesive material. In this manner, the cover layermay be peeled off to expose the adhesive material, and the adhesive sideof the disposable housing 20 may be placed against the user-patient, forexample against the skin of the user-patient. Thus in some embodiments,the delivery device 12 may be attached to the skin of the user-patient.

In other embodiments, the disposable housing 20 and/or the remainingportions of the delivery device 12 may be worn or otherwise attached onor underneath clothing of the user-patient. Similarly, the deliverydevice 12 may be supported by any suitable manner, such as, but notlimited to, on a belt, in a pocket, and the like. Representativeexamples of such delivery devices 12, and delivery devices in general,may include, but is not limited to, the MiniMed Paradigm 522 InsulinPump, MiniMed Paradigm 722 Insulin Pump, MiniMed Paradigm 515 InsulinPump, MiniMed Paradigm 715 Insulin Pump, MiniMed Paradigm 512R InsulinPump, MiniMed Paradigm 712R Insulin Pump, MiniMed 508 Insulin Pump,MiniMed 508R Insulin Pump, and any other derivatives thereof.

The reservoir system 40 may be configured for containing or holdingfluidic media, such as, but not limited to insulin. In variousembodiments, the reservoir system 40 may include a hollow interiorvolume for receiving fluidic media, such as, but not limited to, acylinder-shaped volume, a tubular-shaped volume, or the like. In someembodiments, the reservoir system 40 may be provided as a cartridge orcanister for containing fluidic media. In various embodiments, thereservoir system 40 can be refilled with fluidic media. In furtherembodiments, the reservoir system 40 is pre-filled with fluidic media.

The reservoir system 40 may be supported by the disposable housing 20 inany suitable manner. For example, the disposable housing 20 may beprovided with projections or struts (not shown), or a trough feature(not shown), for holding the reservoir system 40. In some embodiments,the reservoir system 40 may be supported by the disposable housing 20 ina manner that allows the reservoir system 40 to be removed from thedisposable housing 20 and replaced with another reservoir.Alternatively, or in addition, the reservoir system 40 may be secured tothe disposable housing 20 by a suitable adhesive, a strap, or othercoupling structure.

In various embodiments, the reservoir system 40 may include at least oneport 41 for allowing fluidic media to flow into and/or flow out of theinterior volume of the reservoir system 40. In some embodiments, theinfusion path 50 may include a connector 56, a tube 54, and a needleapparatus 52. The connector 56 of the infusion path 50 may beconnectable to the port 41 of the reservoir system 40. In variousembodiments, the disposable housing 20 may be configured with an openingnear the port 41 of the reservoir system 40 for allowing the connector56 of the infusion path 50 to be selectively connected to anddisconnected from the port 41 of the reservoir system 40.

In various embodiments, the port 41 of the reservoir system 40 may becovered with or supports a septum (not shown in FIG. 2), such as aself-sealing septum, or the like. The septum may be configured toprevent fluidic media from flowing out of the reservoir system 40through the port 41 when the septum is not pierced. In addition, invarious embodiments, the connector 56 of the infusion path 50 mayinclude a needle for piercing the septum covering the port 41 of thereservoir system 40 to allow fluidic media to flow out of the interiorvolume of the reservoir system 40.

Examples of needle/septum connectors can be found in U.S. patentapplication Ser. No. 10/328,393, filed Dec. 22, 2003, entitled“Reservoir Connector,” which is incorporated herein by reference in itsentirety. In other alternatives, non-septum connectors such as Luerlocks, or the like may be used. In various embodiments, the needleapparatus 52 of the infusion path 50 may include a needle that is ableto puncture the skin of the user-patient. In addition, in variousembodiments, the tube 54 connects the connector 56 with the needleapparatus 52 and may be hollow, such that the infusion path 50 is ableto provide a path to allow for the delivery of fluidic media from thereservoir system 40 to the body of a user-patient.

The durable housing 30 of the delivery device 12 in accordance withvarious embodiments of the present invention includes a housing shellconfigured to mate with and secure to the disposable housing 20. Thedurable housing 30 and the disposable housing 20 may be provided withcorrespondingly shaped grooves, notches, tabs, or other suitablefeatures that allow the two parts to connect together easily, bymanually pressing the two housings together, by twist or threadedconnection, or other suitable manner of connecting the parts that iswell known in the mechanical arts.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be connected to each other using a twist action. Thedurable housing 30 and the disposable housing 20 may be configured to beseparable from each other when a sufficient force is applied todisconnect the two housings from each other. For example, in someembodiments the disposable housing 20 and the durable housing 30 may besnapped together by friction fitting. In various embodiments, a suitableseal, such as an o-ring seal, may be placed along a peripheral edge ofthe durable housing 30 and/or the disposable housing 20 to provide aseal against water entering between the durable housing 30 and thedisposable housing 20.

The durable housing 30 of the delivery device 12 may support a drivedevice (not shown in FIG. 2), including a motor and a drive devicelinkage portion, for applying a force to fluidic media within thereservoir system 40 to force fluidic media out of the reservoir system40 and into an infusion path, such as the infusion path 50, for deliveryto a user-patient. For example, in some embodiments, an electricallydriven motor may be mounted within the durable housing 30 withappropriate linkage for operatively coupling the motor to a plunger arm(not shown in FIG. 2) connected to a plunger head (not shown in FIG. 2)that is within the reservoir system 40 and to drive the plunger head ina direction to force fluidic media out of the port 41 of the reservoirsystem 40 and to the user-patient.

Also, in some embodiments, the motor may be controllable to reversedirection to move the plunger arm and the plunger head to cause fluid tobe drawn into the reservoir system 40 from a patient. The motor may bearranged within the durable housing 30 and the reservoir system 40 maybe correspondingly arranged on the disposable housing 20, such that theoperable engagement of the motor with the plunger head, through theappropriate linkage, occurs automatically upon the user-patientconnecting the durable housing 30 with the disposable housing 20 of thedelivery device 12. Further examples of linkage and control structuresmay be found in U.S. patent application Ser. No. 09/813,660, filed Mar.21, 2001, entitled “Control Tabs for Infusion Devices and Methods ofUsing the Same,” which is incorporated herein by reference in itsentirety.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be made of suitably rigid materials that maintain theirshape, yet provide sufficient flexibility and resilience to effectivelyconnect together and disconnect, as described above. The material of thedisposable housing 20 may be selected for suitable compatibility withskin. For example, the disposable housing 20 and the durable housing 30of the delivery device 12 may be made of any suitable plastic, metal,composite material, or the like. The disposable housing 20 may be madeof the same type of material or a different material relative to thedurable housing 30. In some embodiments, the disposable housing 20 andthe durable housing 30 may be manufactured by injection molding or othermolding processes, machining processes, or combinations thereof.

For example, the disposable housing 20 may be made of a relativelyflexible material, such as a flexible silicone, plastic, rubber,synthetic rubber, or the like. By forming the disposable housing 20 of amaterial capable of flexing with the skin of a user-patient, a greaterlevel of user-patient comfort may be achieved when the disposablehousing 20 is secured to the skin of the user-patient. In addition, aflexible disposable housing 20 may result in an increase in site optionson the body of the user-patient at which the disposable housing 20 maybe secured.

In the embodiment illustrated in FIG. 2, the delivery device 12 isconnected to the sensing device 14 through a connection element 17 ofthe sensing device 14. The sensing device 14 may include a sensor 15that includes any suitable biological or environmental sensing device,depending upon a nature of a treatment to be administered by thedelivery device 12. For example, in the context of delivering insulin toa diabetes patient, the sensor 15 may include a blood glucose sensor, orthe like.

In some embodiments, the sensor 15 may include a continuous glucosesensor. The continuous glucose sensor may be implantable within the bodyof the user-patient. In other embodiments, the continuous glucose sensormay be located externally, for example on the skin of the user-patient,or attached to clothing of the user-patient. In such embodiments, fluidmay be drawn continually from the user-patient and sensed by thecontinuous glucose sensor. In various embodiments, the continuousglucose sensor may be configured to sense and/or communicate with theCCD 16 continuously. In other embodiments, the continuous glucose sensormay be configured to sense and/or communicate with the CCD 16intermittently, for example sense glucose levels and transmitinformation every few minutes. In various embodiments, the continuousglucose sensor may utilize glucose oxidase.

The sensor 15 may be an external sensor that secures to the skin of auser-patient or, in other embodiments, may be an implantable sensor thatis located in an implant site within the body of the user-patient. Infurther alternatives, the sensor may be included with as a part or alongside the infusion cannula and/or needle, such as for example as shown inU.S. patent application Ser. No. 11/149,119, filed Jun. 8, 2005,entitled “Dual Insertion Set,” which is incorporated herein by referencein its entirety. In the illustrated example of FIG. 2, the sensor 15 isan external sensor having a disposable needle pad that includes a needlefor piercing the skin of the user-patient and enzymes and/or electronicsreactive to a biological condition, such as blood glucose level or thelike, of the user-patient. In this manner, the delivery device 12 may beprovided with sensor data from the sensor 15 secured to the user-patientat a site remote from the location at which the delivery device 12 issecured to the user-patient.

While the embodiment shown in FIG. 2 may include a sensor 15 connectedby the connection element 17 for providing sensor data to sensorelectronics (not shown in FIG. 2) located within the durable housing 30of the delivery device 12, other embodiments may employ a sensor 15located within the delivery device 12. Yet other embodiments may employa sensor 15 having a transmitter for communicating sensor data by awireless communication link with receiver electronics (not shown in FIG.2) located within the durable housing 30 of the delivery device 12. Invarious embodiments, a wireless connection between the sensor 15 and thereceiver electronics within the durable housing 30 of the deliverydevice 12 may include a radio frequency (RF) connection, an opticalconnection, or another suitable wireless communication link. Furtherembodiments need not employ the sensing device 14 and, instead, mayprovide fluidic media delivery functions without the use of sensor data.

As described above, by separating disposable elements of the deliverydevice 12 from durable elements, the disposable elements may be arrangedon the disposable housing 20, while durable elements may be arrangedwithin a separable durable housing 30. In this regard, after aprescribed number of uses of the delivery device 12, the disposablehousing 20 may be separated from the durable housing 30, so that thedisposable housing 20 may be disposed of in a proper manner. The durablehousing 30 may then be mated with a new (un-used) disposable housing 20for further delivery operation with a user-patient.

FIG. 3 illustrates an example of the delivery device 12 in accordancewith another embodiment of the present invention. The delivery device 12of the embodiment of FIG. 3 is similar to the delivery device 12 of theembodiment of FIG. 2. While the delivery device 12 in the embodimentillustrated in FIG. 2 provides for the durable housing 30 to cover thereservoir system 40, the delivery device 12 in the embodiment of FIG. 3provides for the durable housing 30 to secure to the disposable housing20 without covering the reservoir system 40. The delivery device 12 ofthe embodiment illustrated in FIG. 3 includes the disposable housing 20,and the disposable housing 20 in accordance with the embodimentillustrated in FIG. 3 includes a base 21 and a reservoir retainingportion 24. In one embodiment, the base 21 and reservoir retainingportion 24 may be formed as a single, unitary structure.

The base 21 of the disposable housing 20 may be configured to besecurable to a body of a user-patient. The reservoir-retaining portion24 of the disposable housing 20 is configured to house the reservoirsystem 40. The reservoir-retaining portion 24 of the disposable housing20 may be configured to have an opening to allow for the port 41 of thereservoir system 40 to be accessed from outside of thereservoir-retaining portion 24 while the reservoir system 40 is housedin the reservoir-retaining portion 24. The durable housing 30 may beconfigured to be attachable to and detachable from the base 21 of thedisposable housing 20. The delivery device 12 in the embodimentillustrated in FIG. 3 includes a plunger arm 60 that is connected to orthat is connectable to a plunger head (not shown in FIG. 3) within thereservoir system 40.

FIG. 4 illustrates another view of the delivery device 12 of theembodiment of FIG. 3. The delivery device 12 of the embodimentillustrated in FIG. 4 includes the disposable housing 20, the durablehousing 30, and the infusion path 50. The disposable housing 20 in theembodiment of FIG. 4 includes the base 21, the reservoir-retainingportion 24, and a peelable cover layer 25. The peelable cover layer 25may cover an adhesive material on the bottom surface 22 of the base 21.The peelable cover layer 25 may be configured to be peelable by auser-patient to expose the adhesive material on the bottom surface 22 ofthe base 21. In some embodiments, there may be multiple adhesive layerson the bottom surface 22 of the base 21 that are separated by peelablelayers.

The infusion path 50 in accordance with the embodiment of the presentinvention illustrated in FIG. 4 includes the needle 58 rather than theconnector 56, the tube 54, and the needle apparatus 52 as shown in theembodiment of FIG. 2. The base 21 of the disposable housing 20 may beprovided with an opening or pierceable wall in alignment with a tip ofthe needle 58, to allow the needle 58 to pass through the base 21 andinto the skin of a user-patient under the base 21, when extended. Inthis manner, the needle 58 may be used to pierce the skin of theuser-patient and deliver fluidic media to the user-patient.

Alternatively, the needle 58 may be extended through a hollow cannula(not shown in FIG. 4), such that upon piercing the skin of theuser-patient with the needle 58, an end of the hollow cannula is guidedthrough the skin of the user-patient by the needle 58. Thereafter, theneedle 58 may be removed, leaving the hollow cannula in place, with oneend of the cannula located within the body of the user-patient and theother end of the cannula in fluid flow connection with fluidic mediawithin the reservoir system 40, to convey pumped infusion media from thereservoir system 40 to the body of the user-patient.

FIG. 5A illustrates a durable portion 8 of the delivery device 12 (referto FIG. 3) in accordance with an embodiment of the present invention.FIG. 5B illustrates a section view of the durable portion 8 inaccordance with an embodiment of the present invention. FIG. 5Cillustrates another section view of the durable portion 8 in accordancewith an embodiment of the present invention. With reference to FIGS. 5A,5B, and 5C, in various embodiments, the durable portion 8 may includethe durable housing 30, and a drive device 80. The drive device 80 mayinclude a motor 84 and a drive device linkage portion 82.

In various embodiments, the durable housing 30 may include an interiorvolume for housing the motor 84, the drive device linkage portion 82,other electronic circuitry, and a power source (not shown in FIGS. 5A,5B, and 5C). In addition, in various embodiments, the durable housing 30may be configured with an opening 32 for receiving a plunger arm 60(refer to FIG. 3). In addition, in various embodiments, the durablehousing 30 may include one or more connection members 34, such as tabs,insertion holes, or the like, for connecting with the base 21 of thedisposable housing 20 (refer to FIG. 3).

FIG. 6A illustrates a disposable portion 9 of the delivery device 12(refer to FIG. 3) in accordance with an embodiment of the presentinvention. FIG. 6B illustrates a section view of the disposable portion9 in accordance with an embodiment of the present invention. FIG. 6Cillustrates another section view of the disposable portion 9 inaccordance with an embodiment of the present invention. With referenceto FIGS. 6A, 6B, and 6C, in various embodiments, the disposable portion9 includes the disposable housing 20, the reservoir system 40, theplunger arm 60, and a plunger head 70. In some embodiments, thedisposable housing 20 may include the base 21 and thereservoir-retaining portion 24. In various embodiments, the base 21 mayinclude a top surface 23 having one or more connection members 26, suchas tabs, grooves, or the like, for allowing connections with the one ormore connection members 34 of embodiments of the durable housing 30(refer to FIG. 5B).

In various embodiments, the reservoir system 40 may be housed within thereservoir retaining portion 24 of the disposable housing 20, and thereservoir system 40 may be configured to hold fluidic media. Inaddition, in various embodiments, the plunger head 70 may be disposed atleast partially within the reservoir system 40 and may be moveablewithin the reservoir system 40 to allow fluidic media to fill into thereservoir system 40 and to force fluidic media out of the reservoirsystem 40. In some embodiments, the plunger arm 60 may be connected toor is connectable to the plunger head 70.

Also, in some embodiments, a portion of the plunger arm 60 may extend tooutside of the reservoir-retaining portion 24 of the disposable housing20. In various embodiments, the plunger arm 60 may have a mating portionfor mating with the drive device linkage portion 82 of the drive device80 (refer to FIG. 5C). With reference to FIGS. 5C and 6C, in someembodiments, the durable housing 30 may be snap fitted onto thedisposable housing 20, whereupon the drive device linkage portion 82automatically engages the mating portion of the plunger arm 60.

When the durable housing 30 and the disposable housing 20 are fittedtogether with the drive device linkage portion 82 engaging or matingwith the plunger arm 60, the motor 84 may be controlled to drive thedrive device linkage portion 82 and, thus, move the plunger arm 60 tocause the plunger head 70 to move within the reservoir system 40. Whenthe interior volume of the reservoir system 40 is filled with fluidicmedia and an infusion path is provided from the reservoir system 40 tothe body of a user-patient, the plunger head 70 may be moved within thereservoir system 40 to force fluidic media from the reservoir system 40and into the infusion path, so as to deliver fluidic media to the bodyof the user-patient.

In various embodiments, once the reservoir system 40 has beensufficiently emptied or otherwise requires replacement, the user-patientmay simply remove the durable housing 30 from the disposable housing 20,and replace the disposable portion 9, including the reservoir system 40,with a new disposable portion having a new reservoir. The durablehousing 30 may be connected to the new disposable housing of the newdisposable portion, and the delivery device including the new disposableportion may be secured to the skin of a user-patient, or otherwiseattached to the user-patient.

In various other embodiments, rather than replacing the entiredisposable portion 9 every time the reservoir system 40 is emptied, thereservoir system 40 may be refilled with fluidic media. In someembodiments, the reservoir system 40 may be refilled while remainingwithin the reservoir retaining portion 24 (refer to FIG. 6B) of thedisposable housing 20. In addition, in various embodiments, thereservoir system 40 may be replaced with a new reservoir (not shown),while the disposable housing 20 may be re-used with the new reservoir.In such embodiments, the new reservoir may be inserted into thedisposable portion 9.

With reference to FIGS. 3, 5A, 6B, and 6C, in various embodiments, thedelivery device 12 may include reservoir status circuitry (not shown),and the reservoir system 40 may include reservoir circuitry (not shown).In various embodiments, the reservoir circuitry stores information suchas, but not limited to, at least one of (i) an identification stringidentifying the reservoir system 40; (ii) a manufacturer of thereservoir system 40; (iii) contents of the reservoir system 40; and (iv)an amount of contents in the reservoir system 40. In some embodiments,the delivery device 12 may include the reservoir status circuitry (notshown), and the reservoir status circuitry may be configured to readdata from the reservoir circuitry (not shown) when the reservoir system40 is inserted into the disposable portion 9.

In various embodiments, the reservoir status circuitry (not shown) maybe further configured to store data to the reservoir circuitry after atleast some of the contents of the reservoir system 40 have beentransferred out of the reservoir system 40 to update information in thereservoir circuitry (not shown) related to an amount of contents stillremaining in the reservoir system 40. In some embodiments, the reservoirstatus circuitry (not shown) may be configured to store data to thereservoir circuitry (not shown) to update information in the reservoircircuitry (not shown) related to an amount of contents remaining in thereservoir system 40 when the reservoir system 40 is inserted into thedisposable portion 9. In some embodiments, the delivery device 12 mayinclude the reservoir status circuitry (not shown) and the reservoirsystem 40 may include the reservoir circuitry (not shown), and thereservoir status circuitry (not shown) may selectively inhibit use ofthe delivery device 12 or may selectively provide a warning signal basedon information read by the reservoir status circuitry (not shown) fromthe reservoir circuitry (not shown).

FIGS. 7A-11 illustrate a reservoir system 100. The reservoir system 100and/or a process 200 (discussed later) for filling the reservoir system100 (e.g., reservoir body 110) may be similar to or employed as anembodiment of the reservoir system 40 (e.g., FIGS. 1-6C). Although thereservoir system 100 and/or a process 200 (discussed later) for fillingthe reservoir system 100 may include features similar or used with theembodiments of FIGS. 1-6C, it should be understood that the reservoirsystem 100 and/or the process 200 for filling the reservoir system 100may also include some or all of the same features and operate in amanner similar to that shown and described in the embodiments of FIGS.13-14D. In addition, some or all of the features shown in FIGS. 1-6C and13-14D may be combined in various ways and included in the embodimentsshown in FIGS. 7A-12. Likewise, it should be understood that any of thefeatures of the embodiments of FIGS. 7A-12 may be combined or otherwiseincorporated into any of the other embodiments of FIGS. 7A-12 as well asany other embodiment herein discussed.

The reservoir system 100 may include, but is not limited to, a containeror reservoir body 110, a plunger head 120, a plunger arm 126, and aplunger arm casing 130. The reservoir body 110 may have an interiorvolume 112 for containing fluidic media. In various embodiments, thereservoir body 110 may be made of various suitable materials, including,but not limited to, glass, plastic, TOPAS® polymers (or any other cyclicolefin copolymer (or polymer)), or the like. The reservoir body 110 maybe of any suitable shape and/or size and may be adapted to hold anyvolume of fluidic media depending on needs of user-patients.

The reservoir body 110 may have a port 116 for expelling fluidic mediacontained in the interior volume 112 of the reservoir body 110. Invarious embodiments, the port 116 of the reservoir body 110 may be forallowing fluidic media to flow into the interior volume 112 of thereservoir body 110 (i.e., to fill the interior volume 112 of thereservoir body 110). In other embodiments, the interior volume 112 ofthe reservoir body 110 may be filled with fluidic media through an end117, which may be open. For example, the end 117 may be on an oppositeside of the reservoir body 110 from the port 116. In other embodiments,the interior volume 112 of the reservoir body 110 may be filled withfluidic media through a second port (not shown), which may be, forexample, on a same side of the reservoir body 410 as the port 116.

The plunger head 120 may be located within the reservoir body 110 andmay be moveable in an axial direction of the reservoir body 110 toexpand (e.g., FIG. 7A) or contract (e.g., FIG. 7B) the interior volume112 of the reservoir body 110. The plunger head 120 may be advancedwithin the reservoir body 110 to expel fluidic media contained in theinterior volume 112 of the reservoir body 110 out the port 116 of thereservoir body 110. The plunger head 120 or a portion thereof may bemade of Bromobutyl rubber, silicone rubber, or any other suitablematerial and/or any derivative thereof. The plunger head 120 may have afront portion 122 and a rear portion 123.

The front portion 122 of the plunger head 120 may be in contact withfluidic media contained in the interior volume 112 of the reservoir body110. In some embodiments, the front portion 122 of the plunger head 120may comprise a material compatible with fluidic media contained in theinterior volume 112 of the reservoir body 110. In such embodiments, anynumber of the remaining portions of the plunger head 120, such as therear portion 123 of the plunger head 120, the plunger arm 126, and theplunger arm casing 130 may be made of a similar material or of anysuitable material, including, but not limited to, materials incompatiblewith fluidic media contained in the interior volume 112 of the reservoirbody 110.

In some embodiments, where the interior volume 112 of the reservoir body110 is for containing insulin, the front portion 122 of the plunger head120 may comprise an insulin compatible material, such as, but notlimited to, polyethylene, or the like. In such embodiments, any numberof the remaining portions of the plunger head 120, such as the rearportion 123 of the plunger head 120, the plunger arm 126, and theplunger arm casing 130 may be made of an insulin compatible material,which may be the same or different from that of the front portion 122,or of any suitable material, including, but not limited to, materialsincompatible with insulin.

In some embodiments, the front portion 122 of the plunger head 120 maybe removably attachable to the plunger head 120. For example, the frontportion 122 of the plunger head 120 may have one or more tabs (notshown) configured to fit into one or more apertures (not shown) locatedon the plunger head 120. In various embodiments, the front portion 122of the plunger head 120 may be secured to the plunger head 120 in anysuitable manner, such as, but not limited to, a snap-fitting, anadhesive, friction fitting, laser welding, magnetic coupling, or thelike.

The rear portion 123 of the plunger head 120 may be connected orconnectable to an end of the plunger arm 126 in any suitable manner. Forexample, the rear portion 123 of the plunger head 120 may include anaperture 129 (e.g., FIG. 11) for receiving a tab 128 or the like of theplunger arm 126. The tab 128 may be snap-fit into the aperture 129 toconnect the plunger arm 126 to the rear portion 123 of the plunger head120. In various other embodiments, the plunger arm 126 may be connectedto the plunger head 120 and/or the rear portion 123 of the plunger head120 in any suitable manner, such as, but not limited to, an adhesive,friction fitting, laser welding, magnetic coupling, or the like.

The plunger arm 126 may be moveable in an axial direction within theplunger arm casing 130 and the reservoir body 110. In some embodiments,the plunger arm 126 and the rear portion 123 of the plunger head 120 maybe integral to one another. In other embodiments, the plunger arm 126and the rear portion 123 of the plunger head 120 may be separatecomponents.

The plunger arm 126 may include an engagement side 128 for operativelyengaging a drive member 140, drive linkage, or the like. For example,the engagement side 128 of the plunger arm 126 and the drive member 140may be complementing gears, complementing threaded members, or the like,that may operatively engage one another. The drive member 140 may be adrive screw, drive rack, or the like. The drive member 140 may beconnected to a motor (not shown) to move the drive member 140 to causethe plunger arm 126 to move within the plunger arm casing 130 and thereservoir body 110 and, thus move the plunger arm 120 within thereservoir body 110 to expand or contact the interior volume 112 of thereservoir body 110.

The plunger arm casing 130 may be for supporting the plunger arm 126 asthe plunger arm 126 moves along the plunger arm casing 130, for example,by the drive member 140. At least one side of the plunger arm 126 may bein contact with one or more interior sides of the plunger arm casing130. In some embodiments, the plunger arm casing 130 may be for aligningthe plunger arm 126 as the plunger arm 126 moves along the reservoirbody 110, for example, by the drive member 140. In addition, the plungerarm casing 130 may be sized and configured to substantially envelop theplunger arm 126, for example, in a case where the plunger head 120 isdrawn substantially near the end 117 of the reservoir body 110 (e.g.,FIG. 7A). Thus in some embodiments, the plunger arm 126 may be locatedwithin the reservoir body 110 and/or the plunger arm casing 130 duringuse of the reservoir system 100 by a user-patient (e.g., during deliveryof fluidic media to the user-patient).

In some embodiments, the plunger arm casing 130 may have an opening 136for allowing a portion of the engagement side 128 of the plunger arm 126to operatively engage the drive member 140. In such embodiments, theplunger arm 126 may be surrounded by the plunger arm casing 130 and/orthe reservoir body 110. Accordingly in such embodiments, only theportion of the engagement side 128 of the plunger arm 126 exposed by theopening 136 may be free from (i.e., not surrounded by) the plunger armcasing 130 and/or the reservoir body 110. This may allow the drivemember 140 to operatively engage the engagement side 128 of the plungerarm 126 while the plunger arm 126 or a portion thereof remains in theplunger arm casing 130 and/or the reservoir body 110. Thus, the opening136 may form a window or the like through which the drive member 140 hasaccess to the plunger arm 126.

The reservoir system 100 may include a reservoir cover (or casing) 134that may be sized and configured to cover the end 117 of the reservoirbody 110. For example, in a case where the port 116 is located on afirst end of the reservoir body 110, a second end opposite the first endmay be the end 117 of the reservoir body 110 and may be covered by thereservoir cover 134. The reservoir cover 134 may be integral with theplunger arm casing 130.

In other embodiments, the reservoir cover 134 may be separate from theplunger arm casing 130. For example, the reservoir cover 134 may beremovably attachable to the plunger arm casing 130. In such embodiments,the reservoir cover 134 may be connected to or connectable to theplunger arm casing 130 in any suitable manner, such as those previouslydescribed.

In some embodiments, the end 117 of the reservoir body 110 may be open.The reservoir cover 134 may cover the open end 117 of the reservoir body110 or be configured to fit within or to the open end 117 of thereservoir body 110 to seal or close the open end 117 of the reservoirbody 110. The open end 117 may allow fluidic media to flow into theinterior volume 112 of the reservoir body 110 and/or the plunger head120 and/or at least a portion of the plunger arm 126 attached to theplunger head 120 to be insertable into the reservoir body 110, forexample, before the reservoir cover 134 is placed in/on the reservoirbody 110 to cover the open end 117 of the reservoir body 110.

For example, the reservoir cover 134 may include one or more tabs 138sized and configured to fit within one or more recesses 118 on the end117 of the reservoir body 110 to attach or otherwise fit the reservoircover 134 to the reservoir body 110 to substantially close the reservoirbody 110 after the plunger head 120 and/or at least a portion of theplunger arm 126 have been placed in the reservoir body 110. However, thereservoir cover 134 may be connected to or connectable to the reservoirbody 110 in any suitable manner, such as those previously described.

In some embodiments, the reservoir cover 134 and/or the plunger armcasing 130 may be configured for minimizing an expansion of thereservoir body 110 in one or more dimensions. In such embodiments, byfitting the reservoir cover 134 to the back of the reservoir body 110,the reservoir cover 134 may help retain a shape of the reservoir body110.

A seal member 124, such as an o-ring or the like, may be positionedbetween the reservoir body 110 and a portion of the plunger head 120. Aportion 125 of the seal member 124 may be in contact with the reservoirbody 110. The interior volume 112 of the reservoir body 110 may be onone side of the seal member 124. The reservoir body 110 may have achamber 152 located on an opposite side of the seal member 124 from theinterior volume 112 of the reservoir body 110.

The seal member 124 may be for substantially preventing fluidic mediafrom flowing from the interior volume 112 of the reservoir body 110 tothe chamber 152 of the reservoir body 110. The chamber 152 of thereservoir body 110 may be located between the seal member 124 and thereservoir cover 134 in a case where the plunger head 120 is in thereservoir body 110 and the reservoir cover 134 and/or the plunger armcasing 130 are fitted or otherwise attached to the reservoir body 110.In some embodiments, the seal member 124 may be located between thefront portion 122 and the rear portion 123 of the plunger head 120.

In some embodiments, the reservoir system 100 may include at least onesupport flange 127 positioned on the plunger arm 126 and the rearportion 123 of the plunger head 120. The support flange 127 may provideadditional structural strength to the plunger arm 126 and/or the plungerhead 120. For example, the support flange 127 may have a triangularconfiguration and be positioned with one side of the support flange 127connected to a surface of the plunger arm 126 and a second side of thesupport flange 127 connected to the rear portion 123 of the plunger head120. In addition to or alternative to, a second support flange (notshown) may be positioned with one side of the second support flange (notshown) connected to a different surface of the plunger arm 126 and asecond side of the second support flange (not shown) connected to therear portion 123 of the plunger head 120.

In various embodiments, the plunger arm 126 may include an element 144(e.g., a protrusion) for actuating a sensor (not shown) (e.g., a volumesensor) or other circuitry. In other embodiments, the element 144 may bethe sensor or similar circuitry. Examples of systems incorporating suchelements and/or sensors (e.g., volume sensors) are disclosed in, but notlimited to, U.S. application Ser. No. 12/649,619 (filed Dec. 30, 2009),which is herein incorporated by reference in its entirety. The element144 may be arranged at any suitable location, for example, on theplunger arm 126 to allow for movement of the element 144 along with theplunger arm 126. In other embodiments, the element 144 may be arrangedon arm 142 or other portion extending from the plunger arm 126 (or othersuitable component) to facilitate interaction of the element 144 withthe sensor or other item with which the element 144 is interacting.

FIG. 12 illustrates a flowchart for a process 200 for filling areservoir, such as the reservoir body 110 of FIGS. 7A-11. With referenceto FIGS. 7A-12, in step S202, an interior volume 112 of a reservoir body110 may be filled with fluidic media through an open end 117 of thereservoir body 110. The interior volume 112 of the reservoir body 110may be filled with fluidic media, for example, in an “asepticenvironment.” The reservoir body 110 may be filled in any suitablemanner such as, but not limited to, pressure filling, vacuum filling,gravity filling (e.g., pouring), and/or the like. The asepticenvironment as applied in the pharmaceutical/medical industry may referto an environment in which assembly of sterilized components and productmay be processed in a specialized clean environment. For example, theaseptic environment may be one in which living pathogenic organisms areabsent and/or is free of contaminants.

Next in step S204, after the interior volume 112 of the reservoir body110 is filled with a desired amount, a plunger head 120 may be insertedinto the reservoir body 110 through the open end 117 of the reservoirbody 110. The plunger head 120 may be positioned to contact the fluidicmedia contained in the interior volume 112 of the reservoir body 110.The plunger head 120 may serve to seal or otherwise substantiallyprevent fluidic media from flowing past the plunger head 120, forexample, out the reservoir body 110. The plunger head 120 may beinserted into the reservoir body 110 through the open end 117 of thereservoir body 110, for example, in an aseptic environment as wasdescribed previously. In some embodiments, this aseptic environment maybe a different aseptic environment than the aseptic environment wherethe reservoir body 110 is filled with fluidic media.

Next in step S206, after the plunger head 120 is inserted into thereservoir body 110, a plunger arm 126 may be connected to the plungerhead 120. For instance, as previously described, a rear portion 123 ofthe plunger head 120 may be connected or connectable to an end of theplunger arm 126 in any suitable manner. For example, the rear portion123 of the plunger head 120 may include an aperture 129 for receiving atab 128 or the like of the plunger arm 126. The tab 128 may snap-fit tothe aperture 129 to connect the plunger arm 126 to the rear portion 123of the plunger head 120. In various other embodiments, the plunger arm126 may be connected to the plunger head 120 and/or the rear portion 123of the plunger head 120 in any suitable manner, such as, but not limitedto, an adhesive, friction fitting, laser welding, magnetic coupling, orthe like.

In some embodiments, the plunger arm 126 may be connected to the plungerhead 120 in a non-aseptic environment, such as a “clean environment,” orthe like. The clean environment may be a conventional human scaleclassified clean room or an environment engineered to further reduce thelikelihood of contamination by reducing (or as much as is possibleeliminating) direct human contact with the product and components beingassembled “aseptically.” Generally, a clear environment is relativelyfree of pathogens and/or contaminants, but to a lesser degree than anaseptic environment.

For example, the reservoir body 110 containing fluidic media and theplunger head 120 may be removed from the aseptic environment(s) in whichthe reservoir body 110 is filled with fluidic media and receives theplunger head 120, and then placed in a clean environment (e.g., one thatis relatively free of contaminants, but not as much as the asepticenvironment) at which point the plunger arm 126 may be connected to theplunger head 120. In other words, in such embodiments, the plunger arm126 may be connected to the plunger head 120 in a different environmentfrom the environment(s) of steps S202 and S204. In other embodiments,the plunger arm 126 may be connected to the plunger head 120 in anysuitable environment, including (but not limited to) an asepticenvironment.

In other embodiments, the plunger arm 126 may be attached or integratedwith the plunger head 120 before the plunger head 120 is placed in thereservoir body 110. Thus, by inserting the plunger head 120 into thereservoir body 110, at least a portion of the plunger arm 126 is alsoplaced within the reservoir body 110. In other words, a plunger head maybe placed in a reservoir body as part of step S204 along with anattached or integrated plunger arm or a portion thereof, for example, inan aseptic environment.

In step S208, a plunger arm casing 130 for supporting at least a portionof the plunger arm 126 may be attached to the reservoir body 110. Theplunger arm casing 130 may include a portion, such as a reservoir cover(or casing) 134 that may be sized and configured to cover the open end117 of the reservoir body 110 and/or otherwise attach to the reservoirbody 110. As such, the reservoir cover 134 may cover the open end 117 ofthe reservoir body 110 or be configured to fit within or onto the openend 117 of the reservoir body 110 to seal or close the open end 117 ofthe reservoir body 110. For example, the reservoir cover 134 may beconfigured to be friction-fit with an inner rear portion 119 of thereservoir body 110. As such, the plunger arm casing 130 may cover theopen end 117 and be attached to the reservoir body 110. Or for example,the reservoir cover 134 may include one or more tabs 138 sized andconfigured to fit within one or more recesses 118 on or near the openend 117 of the reservoir body 110 to fit the reservoir cover 134 to thereservoir body 110 to substantially close the reservoir body 110 afterthe plunger head 120 and/or at least a portion of the plunger arm 126have been placed in the reservoir body 110.

In some embodiments, the plunger arm casing 130 and/or the reservoircover 134 may be welded (e.g., laser welded) or the like to thereservoir body 110. Such embodiments, may allow, for example, forsubstantially preventing substances (e.g., contaminants, fluidic media)from going in to or out of the reservoir body 110.

In some embodiments, the reservoir body 110 containing fluidic media andthe plunger head 120 may be removed from the aseptic environment(s) inwhich the reservoir body 110 is filled with fluidic media and receivesthe plunger head 120, and then placed in a non-aseptic environment, suchas a clean environment at which point the plunger arm casing 130 and thereservoir cover 134 may be connected to the reservoir body 110. In otherwords, in such embodiments, the plunger arm casing 130 and the reservoircover 134 may be connected to the reservoir body 110 to cover the openend 117 in a different environment from the environment(s) of steps S202and S204. In other embodiments, the plunger arm casing 130 may beconnected to the reservoir body 110 in any suitable environment,including (but not limited to) an aseptic environment.

In various embodiments, step S208 may be performed before step S206 suchthat the plunger arm casing 130 may be attached to the reservoir body110 before the plunger arm 126 is attached to the plunger head 120. Forexample, the plunger arm 126 may be disposed in the plunger arm casing130 prior to the plunger arm casing 130 and/or the reservoir cover 134being attached to the reservoir body 110. Once the plunger arm casing130 and/or the reservoir cover 134 is attached to the reservoir body110, the plunger arm 126 may be connected to the plunger head 120. Insome embodiments, the plunger arm 126 may be guided along the plungerarm casing 130 to connect the plunger arm 126 to the plunger head 120,for example, through an opening 139 in the plunger arm casing 130. Forexample, a tool (not shown) may be inserted into the opening 139 toguide or otherwise move the plunger arm 126 along the plunger arm casing130 to connect to the plunger head 120. The plunger arm 126 and/or theplunger head 120 may be adapted to snap-fit together, as describedabove, or connect in any suitable manner, such as (but not limited to)those previously discussed.

In various embodiments, after the plunger arm 126 is connected to theplunger head 120 and the plunger arm casing 130 and/or the reservoircover 134 is connected to the reservoir body 110, other drivecomponents, such as a drive motor (not shown) and/or one or more drivemembers (not shown) operatively connected to the drive motor (not shown)may be operatively connected to the plunger arm 126 as needed. In otherembodiments, the other drive components may be connected to orintegrated with the plunger head 120 before the plunger head 120 isinserted in the reservoir body 110. For example, a plunger head placedin a reservoir body may have a portion (e.g., a plunger arm) forengaging a drive motor or other drive components. In such embodiments,the integrated components or portions thereof may be placed in thereservoir body 110 along with the plunger head 120 as part of step S204,for example.

FIG. 13 illustrates a flowchart for a process 300 for filling areservoir body 410 in accordance with an embodiment of the presentinvention. In various embodiments, the process 300 may be for filling areservoir body 410 or the reservoir body 110 of FIGS. 7A-11 (and/or thereservoir system 40 of FIGS. 1-6C). As such, the reservoir body 410 andrelated components may be like the reservoir body 110 and relatedcomponents of FIGS. 7A-11 (and/or the reservoir system 40 of FIGS.1-6C).

The reservoir body 410 and/or the processor 400 for filling thereservoir body 410 may be similar to or employed as an embodiment of thereservoir body 110 and/or the processor 200 (e.g., FIGS. 7A-12).Although the reservoir body 410 and/or the processor 400 for filling thereservoir body 410 may include features similar or used with theembodiments of FIGS. 7A-12, it should be understood that the reservoirbody 410 and/or the processor 400 for filling the reservoir body 410 mayalso include some or all of the same features and operate in a mannersimilar to that shown and described in the embodiments of FIGS. 1-6C. Inaddition, some or all of the features shown in FIGS. 1-12 may becombined in various ways and included in the embodiments shown in FIGS.13-14D. Likewise, it should be understood that any of the features ofthe embodiments of FIGS. 13-14D may be combined or otherwiseincorporated into any of the other embodiments of FIGS. 13-14D as wellas any other embodiment herein discussed.

With reference to FIGS. 13-14D, the reservoir body 410 may have aninterior volume 412 for containing fluidic media. In variousembodiments, the reservoir body 410 may be made of various suitablematerials, including, but not limited to, glass, plastic, TOPAS®polymers (or any other cyclic olefin copolymer (or polymer)), or thelike. The reservoir body 410 may be of any suitable shape and/or sizeand may be adapted to hold any volume of fluidic media depending onneeds of user-patients.

The reservoir body 410 may have a port 416 for expelling fluidic mediacontained in the interior volume 412 of the reservoir body 410. Invarious embodiments, the port 416 of the reservoir body 410 may be forallowing fluidic media to flow into the interior volume 412 of thereservoir body 410 (i.e., to fill the interior volume 412 of thereservoir body 410). In other embodiments, the interior volume 412 ofthe reservoir body 410 may be filled with fluidic media through an end417, which may be open. For example, the end 417 may be on an oppositeside of the reservoir body 410 from the port 416. In other embodiments,the interior volume 412 of the reservoir body 410 may be filled withfluidic media through a second port (not shown), which may be, forexample, on a same side of the reservoir body 410 as the port 416.

In step S302 (e.g., FIG. 14A), the reservoir body 410 may be scored,pre-cut, perforated, or the like along a perimeter 415 of the reservoirbody 410. The reservoir body 410 may be scored during manufacture orafter manufacture of the reservoir body 410. The perimeter 415 maybisect (i.e., divide) the reservoir body 410 into a first portion 410 aof the reservoir body 410 and a second portion 410 b of the reservoirbody 410. The perimeter 415 may allow for the removal of the secondportion 410 b from the reservoir body 410, thus leaving only the firstportion 410 a of the reservoir body 410. For example, the second portion410 b may be broken off, dissolved, or otherwise removed from thereservoir body 410 to leave the first portion 410 a, which may have anend 415′ corresponding to where the second portion 410 b was removedfrom the reservoir body 410.

In other embodiments, the reservoir body 410 may include any number ofperimeters 415 to allow for a selection from multiple reservoir volumes.In further embodiments, one or more of the multiple perimeters 415 (orportion, such as 410 b, of the reservoir 410) may be formed or otherwiseprovided in a manner different from another perimeter 415 (or portion,such as 410 a of the reservoir 410). In such embodiments, for example,the reservoirs 410 may be sized using different methods based on whichperimeter 415 from which the extraneous portion (e.g., second portion410 b) is removed from the reservoir 410 (e.g., first portion 410 a).

In various embodiments, the perimeter 415 need not extend entirelythrough the reservoir body 410. In such embodiments, the perimeter 415need only penetrate the external surface of the reservoir bodysufficiently to allow the second portion 410 b to be removed from thefirst portion 410 a.

In various embodiments, the perimeter 415 need not extend around theentire circumference (or perimeter) of the reservoir 410. For example,the perimeter 415 may be a series of perforations or slits having asuitable size, shape, and/or number. In such embodiments, the perimeter415 need only sufficiently extend or otherwise be located to allow thesecond portion 410 b to be removed from the first portion 410 a.

In other embodiments, the perimeter 415 may be formed along thereservoir body 410 during manufacture. For example, the reservoir body410 may be molded or otherwise formed with a perimeter 415 that allowsfor removal of the second portion 410 b from the reservoir body 410. Forinstance, a thickness of the reservoir body 110 along the perimeter 415may be less than a thickness of the first portion 410 a and/or aremaining portion of the reservoir body 410. Alternatively, forinstance, the perimeter 415 may comprise perforations that allow thesecond portion 410 b to be removed from the first portion 410 a.

In other embodiments, the second portion 410 b may be formed to allowfor removal of the second portion 410 b from the reservoir body 410. Forexample, a thickness of the second portion 410 b of the reservoir body110 may be less than a thickness of the first portion 410 a and/or aremaining portion of the reservoir body 410.

In some embodiments, the perimeter 415 (or a portion of the reservoirbody 410 corresponding to the perimeter 415) or a portion thereof (e.g.,an external surface of the perimeter 415) may be formed of a differentmaterial from the first portion 410 a and/or the remaining portion ofthe reservoir body 410. The difference in materials between theperimeter 415 and the first portion 410 a and/or a remaining portion ofthe reservoir body 410 may make it easier to remove (e.g., break off ordissolve) the second portion 410 b from the reservoir body 410. Forexample, the reservoir body 410 or portion thereof may be placed in asubstance, such as a liquid or the like, that can dissolve the perimeter415, but not the reservoir body 410.

In some embodiments, the perimeter 415 may be an annular body (notshown) sized and dimensioned to fit around at least a portion of thereservoir body 410. For example, the annular body (not shown) may fitaround, on the reservoir body 410, or in a groove, such as a scoredperimeter as discussed, around the reservoir body. In such embodiments,the annular body (not shown) may be, for example, peeled, dissolved,broken off, or otherwise removed to separate the first portion 410 a andthe second portion 410 b or allow for the first portion 410 a and thesecond portion 410 b to be separated more easily. For example, theannular body (not shown) may be removed to expose a scored groove orperimeter that seated the annular body (not shown). Then, the secondportion 410 b may be removed the first portion 410 a along the groove.

In other embodiments, the second portion 410 b may be made of adifferent material from the first portion 410 a of the reservoir body410, which may allow the second portion 410 to be removed. For example,the reservoir body 410 or a portion thereof may be placed in asubstance, such as a liquid or the like, that can dissolve the secondportion 410 b, but not the first portion 410 a.

In some embodiments, the perimeter 415 may be configured or otherwiseformed such that the end 415′ may be relatively smooth after the secondportion 410 b is removed from the reservoir body 410. In someembodiments, the perimeter 415 may be substantially parallel to the end417 such that the end 415′ may be substantially parallel to the end 417in a case where the second portion 410 b is removed. In otherembodiments, the perimeter 415 may be scored or otherwise formed in anysuitable shape or pattern. For example, the perimeter 415 may be shapedconvexly or concavely like a meniscus, or shaped or keyed to receive(e.g., 118 in FIGS. 7A-8) a complementing member (e.g., 138 in FIGS.7A-8) and/or received by another component after the second portion 410b is removed.

In various embodiments, it should be noted that the perimeter 415 orportions thereof may be in any configuration or arrangement. Forexample, the perimeter 415 may extend into an external surface of thereservoir body 410 to form a groove around the reservoir body 410. Inother examples, the perimeter 415 may extend away from the externalsurface of the reservoir body 410, such as in a case where the perimeter415 is an annular member 415 arranged on the reservoir body 410. In yetother examples, the perimeter 415 may be flush with the remainder of thereservoir body 410, such as in a case where the perimeter 415 is made ofa material different from the reservoir body 410 and seated in a groovearound the reservoir body 410.

In various embodiments, the reservoir body 410 may be manufacturedand/or scored in a non-aseptic environment, such as a “cleanenvironment.” The clean environment may be a conventional human scaleclassified clean room or an environment engineered to further reduce thelikelihood of contamination by reducing (or as much as is possibleeliminating) direct human contact with the product and components beingassembled “aseptically” (described later). In other embodiments, thereservoir body 410 may be manufactured and/or scored in any suitableenvironment, including (but not limited to) an aseptic environment.

Next in step S304 (e.g., FIG. 14B), the interior volume 412 of thereservoir body 410 may be filled with a desired volume of fluidic media.The reservoir body 410 may be filled in any suitable manner such as, butnot limited to, pressure filling, vacuum filling, gravity filling (e.g.,pouring), and/or the like. It should be noted that filling a volume mayrefer to filling the volume in its entirety or a portion thereof. Insome embodiments, the reservoir body 410 may include a fill line 413such that the interior volume 412 of the reservoir body 410 may befilled with fluidic media approximately up to the fill line 413. Thefill line 413 may correspond, for example, to a specific volume (e.g., 2ml, 3 ml, etc.) of fluidic media to be contained in the interior volume412 of the reservoir body 410.

The fill line 413 may be located in the first portion 410 a of thereservoir body 410. For example, in the embodiment shown in FIG. 14B,the fill line 413 is located between the perimeter 415 and the port 416of the reservoir body 410. By filling the interior volume 412 of thereservoir body 410 to the fill line 413, the second portion 410 b may beremoved while mitigating loss of fluidic media from the interior volume412 of the reservoir body 410. Returning to FIGS. 13-14D, for example, areservoir body 410 adapted to contain up to approximately 3 ml offluidic media and having a fill line 413 corresponding to 2 ml offluidic media may be filled with approximately 2 ml of fluidic media ina case where the reservoir body 410 is filled to the fill line 413.Then, as discussed in the disclosure, the second portion 410 b may beremoved (e.g., as shown in FIG. 14D). In further embodiments, the fillline 413 may be sufficiently located from the perimeter 415 to allow forsufficient spacing for placing a plunger head (e.g., plunger head 420)within the reservoir body 410. In other words, the plunger head may bepositioned between the perimeter 415 and the fill line 413. Once thesecond portion 410 b is removed at the perimeter 415, the perimeter 415may correspond to the distal end of the reservoir 410.

Various embodiments may allow for filling not only the first portion 410a, but also additionally, the interior volume 412 of the reservoir body410 may be filled substantially in its entirety so that the firstportion 410 a and the second portion 410 b of the reservoir body 410contain fluidic media. As such, the second portion 410 b need not beremoved from the reservoir body 410. For example, a reservoir body 410adapted to contain up to approximately 3 ml of fluidic media may befilled with approximately 3 ml of fluidic media. In this instance, thesecond portion 410 b is not removed. In further embodiments, theinterior volume 412 of the reservoir body 410 may be filledsubstantially in its entirety, but with sufficient spacing for placing aplunger head (e.g., plunger 420) within the reservoir body 410. In otherwords, the plunger head may be positioned between the end 417 and thefluidic media contained in the interior volume 412 of the reservoir 410.As such, the end 417 may correspond to the distal end of the reservoir410.

In various embodiments, the interior volume 412 of the reservoir body410 may be filled in an “aseptic environment.” The aseptic environmentas it is applied in the pharmaceutical/medical industry may refer to anenvironment in which assembly of sterilized components and product maybe processed in a specialized clean environment. For example, theaseptic environment may be one in which living pathogenic organismsand/or contaminants are absent.

Next in step S306 (e.g., FIG. 14C), a seal member 422, which may be onor a portion of a plunger head 420, may be inserted into the reservoirbody 410 to prevent fluidic media from flowing out of the reservoir body410 or to otherwise seal the interior volume 412 of the reservoir body410. In various embodiments, air to be displaced by the plunger head 420may be removed in any suitable manner. For example, air may be removed(e.g., with a vacuum) through an opening (not shown) (and/or with aneedle through the plunger head 420) in the plunger head 420 or throughthe port 416 (e.g., through a septum (not shown)), The opening may beclosed once sufficient air is removed. In other embodiments, air may beremoved completely (or at least partially) before the plunger head 420is inserted to facilitate insertion of the plunger head 420. The plungerhead 420 may be positioned to contact fluidic media contained in theinterior volume 412 of the reservoir body 410. The plunger head 420 maybe inserted through an opening, such as the end 417, which may be thesame opening in which fluidic media flowed into the interior volume 412of the reservoir body 410. In other embodiments, the opening throughwhich the plunger head 420 may be inserted may be different from theopening (e.g., port 416) in which fluidic media flowed into the interiorvolume 412 of the reservoir body 410.

In other embodiments, the plunger head 420 may be inserted into thereservoir body 410 and then fluidic media may fill the interior volume412 through the plunger head 420, for example, through an opening (notshown) in or along the plunger head 420. Once the interior volume 412 issufficiently filled, the opening in or along the plunger head 420 may beclosed.

The plunger head 420 or a portion thereof may be made of Bromobutylrubber, silicone rubber, or any other suitable material and/or anyderivative thereof. The plunger head 420 may be arranged for movement inan axial direction of the reservoir body 410 to expand (e.g., FIG. 7A)or contract (e.g., FIG. 7B) the interior volume 412 of the reservoirbody 410. The plunger head 420 may be advanceable within the reservoirbody 410 to expel fluidic media contained in the interior volume 412 ofthe reservoir body 410 out the port 416 of the reservoir body 410.

The plunger head 420 may have a front portion 422 and a rear portion423. In a case where the plunger head 420 is in the reservoir body 410,the front portion 422 of the plunger head 420 may be in contact withfluidic media contained in the interior volume 412 of the reservoir body410. In some embodiments, the front portion 422 of the plunger head 420may comprise a material compatible with fluidic media contained in theinterior volume 412 of the reservoir body 410. In such embodiments, anynumber of the remaining portions of the plunger head 420, such as therear portion 423 of the plunger head 420, a plunger arm (not shown) formoving the plunger head 420 along the reservoir body 410, or the likemay be made of a similar material or of any suitable material,including, but not limited to, materials incompatible with fluidic mediacontained in the interior volume 412 of the reservoir body 410. The rearportion 423 of the plunger head 420 may be connected or connectable toan end of the plunger arm (not shown) in any suitable manner, such as,but not limited to, an adhesive, friction fitting, laser welding,magnetic coupling, or the like.

The plunger head 420 may be or may include a seal member 424, such as ano-ring or the like. The seal member 424 may be positioned between thereservoir body 410 and a portion of the plunger head 420. For example,the seal member 424 may be located between the front portion 422 and therear portion 423 of the plunger head 420. A portion of the seal member424 may be in contact with the reservoir body 410. The interior volume412 of the reservoir body 410 may be on one side of the seal member 424.The open end 417 may be located on an opposite side of the seal member424 from the interior volume 412 of the reservoir body 410.

The seal member 424 may be for substantially preventing fluidic mediafrom flowing from the interior volume 412 of the reservoir body 410 pastthe seal member 424, for example, out the end 417 or, in a case wherethe second portion 410 b is to be later removed, into the second portion410 b. Moreover, the plunger head 420 and/or the seal member 424 maysubstantially prevent fragments of the second portion 410 b fromentering the interior volume 412 of the reservoir 410 when the secondportion 410 b is removed from the reservoir body 410. Similarly, theplunger head 420 and/or the seal member 424 may substantially preventany contaminants from flowing into the interior volume 412 of thereservoir body 410.

In some embodiments, for example in cases where the second portion 410 bis to be removed from the reservoir body, the plunger head 420 may bepositioned between the perimeter 415 and the fill line 413 to contactthe fluidic media contained in the interior volume 412 of the reservoirat the fill line 413.

In various embodiments, the plunger head 420 may be placed in thereservoir body 420 in an aseptic environment, such as that previouslydescribed. This aseptic environment may be the same or different fromthe aseptic environment of step S306.

In step S308 (e.g., FIG. 14D), the second portion 410 b may be removedfrom the reservoir body 410. For example, this may occur in a case wherethe interior volume 412 of the reservoir body 410 is filled with fluidicmedia up to the fill line 413 and the plunger head 420 is inserted intothe reservoir body 410 to contact the fluidic media contained in theinterior volume 412 of the reservoir body 410. As previously discussed,the second portion 410 b may be removed from the reservoir body 410along the perimeter 415. Accordingly, a reservoir body can be filledwith a first amount of fluidic media (e.g., 2 ml) and have any excessmaterial (e.g., second portion 410 b) removed to selectively provide afull first reservoir body (e.g., having 2 ml). Alternatively, asdiscussed, a reservoir body may be filled with a second amount offluidic media (e.g., 3 ml) and no part of (or less than that removedfrom) the reservoir body 410 is removed to selectively provide a fullsecond reservoir body (e.g., having 3 ml). Thus, a reservoir body can beused to provide full reservoirs containing different volumes from eachother.

As discussed above, in some embodiments, the end 415′ may besubstantially smooth once the second portion 410 b is removed. In otherembodiments, the end 415′ may be polished or otherwise finished tosubstantially remove any irregularities or protuberances to make the end415′ relatively smooth and/or sufficiently smooth for use by auser-patient for example. In some embodiments, such as in a case wherethe interior volume is filled substantially in its entirety, there maybe no need to remove the second portion 410 b from the reservoir body410.

In some embodiments, the reservoir body 110 containing fluidic media andthe plunger head 420 may be removed from the aseptic environment, andthen placed in a clean environment, such as that previously described,at which point the second portion 410 b may be removed. This maymitigate contaminants (e.g., fragments produced from removing the secondportion 410 b) from contaminating the aseptic environment.

Accordingly, various embodiments allow a filling mechanism (not shown)to selectively fill reservoir bodies with different volumes of fluidicmedia with little or no adjustment to the filling mechanism (not shown).As such, the filling mechanism (not shown) may fill the same type ofreservoir bodies with a selectable amount of fluidic media. For example,scored 3 ml reservoir bodies can be used with a filling mechanism tofill different reservoir volumes, such as 3 ml and 2 ml. Reservoirbodies for containing 3 ml of fluidic media may be produced according tothe steps above (e.g., steps S302-S306). Reservoir bodies for containing2 ml of fluidic media may be produced similarly to the reservoir bodiesfor containing 3 ml of fluidic media and may be then processed accordingto step S308 to remove excess portions (e.g., second portion 410 b) ofthe reservoir bodies.

In various embodiments, the reservoir body 410 may include any number ofperimeters 415 and/or fill lines 413 each corresponding to a differentfill volume as previously described. As such, the filling mechanism (notshown) may fill the same type of reservoir bodies with a plurality ofselectable amounts of fluidic media. Thus in such embodiments, areservoir body can be selectably filled by a filling mechanism with aplurality of different volumes. Portions of the reservoir body that arenot needed (e.g., second portion 410 b) may be then removed.

In further embodiments, any of the steps described in the process 200(refer to FIGS. 7A-12) may be carried out, such as, but not limited to,attaching a plunger arm to the plunger head 420, attaching a reservoircover or plunger arm casing to the end 415′ of the reservoir body 410,attaching drive system components to the plunger arm and/or plunger 420,or the like. In some embodiments, the plunger head 420 may be integratedwith drive system components. For example, the plunger head 420 may beintegrated with a plunger arm, or the like.

The embodiments disclosed herein are to be considered in all respects asillustrative, and not restrictive of the invention. The presentinvention is in no way limited to the embodiments described above.Various modifications and changes may be made to the embodiments withoutdeparting from the spirit and scope of the invention. The scope of theinvention is indicated by the attached claims, rather than theembodiments. Various modifications and changes that come within themeaning and range of equivalency of the claims are intended to be withinthe scope of the invention.

1. A method of making and filling a reservoir with a selectable amountof fluidic media comprising: providing a reservoir body with a wall anda central bore, the reservoir body having a first portion with a firstfluidic capacity, and a second portion axially aligned with the firstportion with an additional fluidic capacity; providing a selectivelybreakable zone that separates the first portion and the second portionof the reservoir body; arranging a plunger head for axial movementwithin the bore at least between the selectively breakable zone and aport of the reservoir body to expel fluidic media in the bore throughthe port of the reservoir body; and selecting whether: to fill only thefirst portion of the reservoir body with fluidic media, in which casethe method includes filling the first portion of the reservoir body withfluidic media, inserting the plunger head to a position in the bore toseal the first portion of the reservoir body, and breaking off the wallat the selectively breakable zone; or to fill the first portion and thesecond portion of the reservoir body with fluidic media, in which casethe method includes filling the first portion and the second portion ofthe reservoir body with fluidic media and inserting the plunger head toa position in the bore to seal the second portion of the reservoir body.2. The method of claim 1, further comprising: scoring a perimeter aroundthe reservoir body to form the selectively breakable zone.
 3. The methodof claim 2, wherein a portion of the wall defining the first portion ofthe reservoir body has a thickness different from a thickness of aportion of the wall defining the second portion of the reservoir body.4. The method of claim 2, further comprising: providing a portion of thereservoir body corresponding to a perimeter made of a different materialthan a material of the first portion of the reservoir body to providesaid selectively breakable zone.
 5. The method of claim 1, wherein theselectively breakable zone comprises perforations around the reservoirbody.
 6. The method of claim 3, wherein the thickness of the firstportion of the reservoir body is less than the thickness of the secondportion of the reservoir body.
 7. The method of claim 1, wherein thesecond portion of the reservoir body is made of a material differentfrom a material of the first portion of the reservoir body.
 8. Themethod of claim 1, wherein the selectively breakable zone is produced byproviding an annular body sized and dimensioned to fit around at least aportion of the reservoir body; the annular body separating the firstportion of the reservoir body and the second portion of the reservoirbody.
 9. The method of claim 1, wherein the filling of the reservoirbody and the insertion of the plunger head in the reservoir body occursin an aseptic environment.
 10. The method of claim 9, wherein thereservoir body is removed from the aseptic environment prior to breakingoff the wall along the selectively breakable zone.
 11. The method ofclaim 1, further comprising: operatively connecting a plunger arm to theplunger head.
 12. The method of claim 11, wherein the plunger arm andthe plunger head are integral with one another.
 13. A method of makingand filling a reservoir with a selectable amount of fluidic mediacomprising: providing a reservoir body with a wall and a central bore,the reservoir body having a first portion with a first fluidic capacity,and a second portion axially aligned with the first portion with anadditional fluidic capacity; providing a plunger head dimensioned tosealingly slide axially within the bore and thereby propel fluidic mediain the bore; providing a selectively breakable zone that separates thefirst portion and the second portion of the reservoir body; selectingwhether: to fill only the first portion of the reservoir body withfluidic media, in which case the method includes filling the firstportion of the reservoir body with fluidic media, inserting the plungerhead to a position in the bore to seal the first portion of thereservoir body, and breaking off the wall at the selectively breakablezone; or to fill the first portion and the second portion of thereservoir body with fluidic media, in which case the method includesfilling the first portion and the second portion of the reservoir bodywith fluidic media and inserting the plunger head to a position in thebore to seal the second portion of the reservoir body; attaching acasing adjacent to at least a portion of the reservoir body, the casingconfigured to envelop at least a portion of a plunger arm operativelyconnected to the plunger head, the casing further configured to allowthe plunger arm to move in an axial direction relative to the reservoirbody and at least partially within the reservoir body.
 14. The method ofclaim 13, further comprising: locating the plunger arm at leastpartially in the casing; and operatively connecting the plunger arm tothe plunger head after the casing is attached to the reservoir body. 15.The method of claim 13, wherein attaching a casing adjacent to at leasta portion of the reservoir body comprises welding the casing to thereservoir body.
 16. The method of claim 15, wherein the casing is laserwelded to the reservoir body.
 17. The method of claim 1, whereinselectively filling the reservoir body comprises filling the reservoirbody to a fill line.
 18. The method of claim 1, wherein a portion of thewall defining the first portion of the reservoir body has a thicknessdifferent from a thickness of a portion of the wall defining the secondportion of the reservoir body.
 19. A method of making and filling areservoir with a selectable amount of fluidic media comprising:providing a reservoir body with a wall and a central bore, the reservoirbody having a first portion with a first fluidic capacity, a secondportion axially aligned with the first portion with a second fluidiccapacity, and a third portion with a third fluidic capacity; providing aplunger head dimensioned to sealingly slide axially within the bore andthereby propel fluidic media in the bore; providing a first selectivelybreakable zone that separates the first portion and the second portionof the reservoir body; providing a second selectively breakable zonethat separates the second portion and the third portion of the reservoirbody; and selecting whether: to fill only the first portion of thereservoir body with fluidic media, in which case the method includesfilling the first portion of the reservoir body with fluidic media,inserting the plunger head to a position in the bore to seal the firstportion of the reservoir body, and breaking off the wall at the firstselectively breakable zone; to fill the first portion and the secondportion of the reservoir body with fluidic media, in which case themethod includes filling the first portion and the second portion of thereservoir body with fluidic media, inserting the plunger head to aposition in the bore to seal the second portion of the reservoir body,and breaking off the wall at the second selectively breakable zone; orto fill the first portion, the second portion, and the third portion ofthe reservoir body with fluidic media, in which case the method includesfilling the first portion, the second portion, and the third portion ofthe reservoir body with fluidic media and inserting the plunger head toa position in the bore to seal the third portion of the reservoir body.20. A system for containing fluidic media, the system comprising: areservoir body having a wall and a central bore, the reservoir bodyhaving a first portion with a first fluidic capacity and a secondportion axially aligned with the first portion with an additionalfluidic capacity; and a plunger head arranged for axial movement withinthe bore to expel fluidic media in the bore through a port of thereservoir body; wherein the wall of the reservoir body includes aselectively breakable zone that separates the first portion and thesecond portion of the reservoir body, the selectively breakable zone forallowing selective filling of the reservoir body such that (i) in a casewhere only the first portion of the reservoir body is to be filled withfluidic media, the plunger head is positioned in the bore to seal thefirst portion of the reservoir body, and the second portion of thereservoir body is removable from the first portion of the reservoir atthe selectively breakable zone; and (ii) in a case where the firstportion and the second portion of the reservoir body are to be filledwith fluidic media, the plunger head is positioned in the bore to sealthe second portion of the reservoir body; and wherein the plunger headis arranged for axial movement to slide at least between the selectivelybreakable zone and the port of the reservoir body.
 21. The method ofclaim 1, wherein the first portion is defined by a first end of thereservoir body and the selectively breakable zone, the first end of thereservoir body having the port of the reservoir body.
 22. The method ofclaim 21, wherein the second portion is defined by the selectivelybreakable zone and a second end of the reservoir body, the second end ofthe reservoir body opposite the first end of the reservoir body.
 23. Themethod of claim 22, wherein the plunger head is arranged to sealinglyslide axially within the bore between the first end and the second ofthe reservoir body.
 24. The method of claim 1, wherein the reservoirbody has a first diameter at a first end of the reservoir body, thefirst end having the port; and wherein the reservoir body has a seconddiameter at the selectively breakable zone, the second diameter beinglarger than the first diameter.
 25. A method of making and filling areservoir with a selectable amount of fluidic media, comprising:providing a reservoir body having a central bore, the reservoir bodycomprising: a first wall portion defining a first interior volume of thecentral bore for containing a first fluidic capacity; and a second wallportion defining a second interior volume of the central bore forcontaining a second fluidic capacity, the second wall portion axiallyaligned with the first wall portion providing a selectively breakablezone that separates the first wall portion and the second wall portion;providing a plunger head arranged for movement along the central bore atleast between the selectively breakable zone and a port of the reservoirbody to expel fluidic media out of the central bore through the port ofthe reservoir body; and selecting whether: (a) to fill only the firstinterior volume with fluidic media, in which case the method comprises(i) filling the first wall portion of the reservoir body with fluidicmedia, (ii) inserting the plunger head to a position in the central boreto seal the first wall portion of the reservoir body, and (iii) removingthe second wall portion at the selectively breakable zone; or (b) tofill the first interior volume and the second interior volume withfluidic media, in which case the method comprises (i) filling the firstwall portion and the second wall portion of the reservoir body withfluidic media and (ii) inserting the plunger head to a position in thecontrol bore to seal the second wall portion of the reservoir body.